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An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-small-cell Lung

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Trial Information

An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer

- Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the IGF-1R

- Dalotuzumab may act through

- Inhibition of IGF-1-mediated cell signaling to cause reductions in tumor growth
and spread

- Antibody dependent cell-mediated cytotoxicity

- In preclinical studies, dalotuzumab improved the activity of an anti-EGFR mAb and
the activity of Erlotinib, a small molecule inhibitor of EGFR

Trial Duration of Treatment: Subjects will continue on the study for as long as their
disease is not progressing and they do not have unmanageable side effects from the

Inclusion Criteria:

- Subject has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
that has relapsed after chemotherapy/chemoratiotherapy.

- Subject has had at least one chemotherapy regimen for recurrent or metastatic

- Subject is 18 years of age or older

- Subject has a performance status of 0-2 on ECOG scale.

- Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

- Subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab)
within 4 weeks

- Subject has not recovered from adverse events from previous therapy within 4 weeks

- Subject has received EGFR-TKI inhibitor/anti-EGFR mAb therapy

- Subject has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy

- Subject has had more than 2 systemic chemotherapies for metastatic disease

- Subject has not completed radiotherapy with complete resolution of toxicities at
least 2 weeks before starting in the study

- Subject is taking part in another clinical study

- Subject has a primary central nervous system tumor

- Subject abuses drugs or alcohol

- Subject is pregnant or breastfeeding

- Subject is HIV positive

- Subject has a history of hepatitis B or C

- Subject is using growth hormone or growth hormone inhibitors

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of the combination treatment; progression-free survival will be assessed using physical examinations, vital signs, ECOG performance status, complete blood count with differential and platelets, serum chemistry, adverse experience

Outcome Time Frame:

After each dose of study drug

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

February 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms